Potentially harmful excipients in drugs: an analysis of labeling practices and adverse drug reactions
8 affiliations
- 1Department of Pharmacy, Children’s Hospital of Fudan University (Xiamen Branch), Xiamen Children’s Hospital
- 2Department of Pharmacy, Quanzhou Women’s and Children’s Hospital
- 3Department of Pharmacy, Women and Children’s Hospital Affiliated to Xiamen University
- 4Department of Pharmacy, Zhongshan Hospital Affiliated to Xiamen University
- 5Department of Pharmacy, Longyan First Affiliated Hospital of Fujian Medical University
- 6Department of Pharmacy, Nanping First Hospital Affiliated to Fujian Medical University
- 7Department of Pharmacy, Fuzhou Children’s Hospital of Fujian Province
- 8Fujian Key Laboratory of Neonatal Diseases, Xiamen Key Laboratory of Neonatal Diseases, Xiamen Children’s Hospital (Children’s Hospital of Fudan University at Xiamen)
Abstract
Background: Excipients play a crucial role in pharmaceutical formulations, however, their safety profile in pediatric populations remains inadequately characterized.
Methods: This retrospective multicenter study was conducted in two phases. Phase one reviewed package inserts of pediatric medications used at seven Fujian hospitals (July 2019–June 2024) to assess excipient labeling. Phase two analyzed associations between potentially harmful excipients (PHEs) exposure and adverse drug reactions using the reporting odds ratio (ROR) method at a single children's hospital.
Results: The rates of excipient labeling exhibited significant variation based on hospital type, drug source, and drug category. In total, 41.3% of pediatric cases and 43.2% of prescriptions included at least one PHE. Benzyl alcohol was associated with application site pain (ROR = 393.20, P < 0.05) and erythema (ROR = 85.84, P < 0.05); thimerosal was linked to application site irritation (ROR = 278.35, P < 0.05) and pruritus (ROR = 115.20, P < 0.05); and sodium citrate was associated with bradycardia (ROR = 157.59, P < 0.05).
Conclusion: The labeling of excipients in pediatric pharmaceutical products is insufficient in the institutions examined, potentially hindering the identification of excipient exposure in clinical practice. The safety signals identified in this study necessitate further systematic investigation and careful consideration within both regulatory and clinical contexts.
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BibTeX
@article{li2026potentially,
title = {{Potentially harmful excipients in drugs: an analysis of labeling practices and adverse drug reactions}},
author = {Su-ping Li and Xia-yang Wu and Jun-kai Ning and Xiao-qing Huang and Yi-juan Shen and Yu-ying Chen and Kai-jun Liao and Feng Weng and You-hong Wang},
journal = {Frontiers in Pharmacology},
year = {2026},
month = oct,
doi = {10.3389/fphar.2026.1949057},
url = {https://www.frontiersin.org/articles/10.3389/fphar.2026.1949057/full},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Potentially harmful excipients in drugs: an analysis of labeling practices and adverse drug reactions
AU - Su-ping Li
AU - Xia-yang Wu
AU - Jun-kai Ning
AU - Xiao-qing Huang
AU - Yi-juan Shen
AU - Yu-ying Chen
AU - Kai-jun Liao
AU - Feng Weng
AU - You-hong Wang
PY - 2026
DA - 2026/10/13
JO - Frontiers in Pharmacology
DO - 10.3389/fphar.2026.1949057
UR - https://www.frontiersin.org/articles/10.3389/fphar.2026.1949057/full
AB - Background: Excipients play a crucial role in pharmaceutical formulations, however, their safety profile in pediatric populations remains inadequately characterized. Methods: This retrospective multicenter study was conducted in two phases. Phase one reviewed package inserts of pediatric medications used at seven Fujian hospitals (July 2019–June 2024) to assess excipient labeling. Phase two analyzed associations between potentially harmful excipients (PHEs) exposure and adverse drug reactions using the reporting odds ratio (ROR) method at a single children's hospital. Results: The rates of excipient labeling exhibited significant variation based on hospital type, drug source, and drug category. In total, 41.3% of pediatric cases and 43.2% of prescriptions included at least one PHE. Benzyl alcohol was associated with application site pain (ROR = 393.20, P < 0.05) and erythema (ROR = 85.84, P < 0.05); thimerosal was linked to application site irritation (ROR = 278.35, P < 0.05) and pruritus (ROR = 115.20, P < 0.05); and sodium citrate was associated with bradycardia (ROR = 157.59, P < 0.05). Conclusion: The labeling of excipients in pediatric pharmaceutical products is insufficient in the institutions examined, potentially hindering the identification of excipient exposure in clinical practice. The safety signals identified in this study necessitate further systematic investigation and careful consideration within both regulatory and clinical contexts.
SN - 1663-9812
ER -